Enlivex Announces Positive Topline Data From Multi-Country, Randomized, Controlled, Phase I/II Trial Evaluating Allocetra in Patients With Moderate-To-Severe Knee Osteoarthritis
Enlivex Therapeutics (NASDAQ:ENLV) announced positive three-month topline data from its Phase I/II trial of Allocetra鈩� for moderate-to-severe knee osteoarthritis. The trial demonstrated significant improvements across all efficacy endpoints, with the treatment arm showing a 24% reduction in knee pain and 26% improvement in knee function versus placebo.
Notably, in age-related primary osteoarthritis patients, the results were even more impressive, showing a 72% reduction in knee pain and 95% improvement in knee function compared to placebo - achieving statistically significant effects in common Phase III primary endpoints. The treatment demonstrated a favorable safety profile with no severe adverse events, showing only mild to moderate, transient, and treatable side effects.
Enlivex Therapeutics (NASDAQ:ENLV) ha reso noti risultati topline positivi a tre mesi dal suo trial di Fase I/II con Allocetra鈩� per l'artrosi del ginocchio da moderata a grave. Lo studio ha mostrato miglioramenti significativi in tutti gli endpoint di efficacia: il braccio trattato ha evidenziato una riduzione del dolore al ginocchio del 24% e un miglioramento della funzione del ginocchio del 26% rispetto al placebo.
Nei pazienti con artrosi primaria legata all'et脿 i risultati sono stati ancora pi霉 rilevanti, con una riduzione del dolore al ginocchio del 72% e un miglioramento della funzione del 95% rispetto al placebo, raggiungendo effetti statisticamente significativi sugli endpoint primari tipici di una Fase III. Il trattamento ha mostrato un profilo di sicurezza favorevole, senza eventi avversi gravi e con effetti collaterali lievi-moderati, transitori e trattabili.
Enlivex Therapeutics (NASDAQ:ENLV) anunci贸 datos topline positivos a tres meses de su ensayo de Fase I/II con Allocetra鈩� para la artrosis de rodilla de moderada a grave. El estudio mostr贸 mejoras significativas en todos los puntos finales de eficacia: el grupo tratado present贸 una reducci贸n del dolor de rodilla del 24% y una mejora de la funci贸n de la rodilla del 26% frente a placebo.
En pacientes con artrosis primaria relacionada con la edad, los resultados fueron a煤n m谩s llamativos, con una reducci贸n del dolor de rodilla del 72% y una mejora de la funci贸n del 95% en comparaci贸n con placebo, logrando efectos estad铆sticamente significativos en los endpoints primarios habituales de Fase III. El tratamiento mostr贸 un perfil de seguridad favorable, sin eventos adversos graves y con efectos secundarios leves a moderados, transitorios y tratables.
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Enlivex Therapeutics (NASDAQ:ENLV) a annonc茅 des donn茅es topline positives 脿 trois mois de son essai de Phase I/II d'Allocetra鈩� pour l'arthrose du genou mod茅r茅e 脿 s茅v猫re. L'essai a montr茅 des am茅liorations significatives sur tous les crit猫res d'efficacit茅聽: le groupe trait茅 a pr茅sent茅 une r茅duction de la douleur au genou de 24% et une am茅lioration de la fonction du genou de 26% par rapport au placebo.
Chez les patients atteints d'arthrose primaire li茅e 脿 l'芒ge, les r茅sultats ont 茅t茅 encore plus marqu茅s, avec une r茅duction de la douleur de 72% et une am茅lioration de la fonction de 95% par rapport au placebo, atteignant des effets statistiquement significatifs sur les crit猫res primaires typiques d'une Phase III. Le traitement a pr茅sent茅 un profil de s茅curit茅 favorable, sans 茅v茅nements ind茅sirables graves et avec seulement des effets secondaires l茅gers 脿 mod茅r茅s, transitoires et traitables.
Enlivex Therapeutics (NASDAQ:ENLV) gab positive Dreimonats-Topline-Daten aus seiner Phase-I/II-Studie zu Allocetra鈩� bei mittel- bis schwerer Kniearthrose bekannt. Die Studie zeigte signifikante Verbesserungen in allen Wirksamkeitsendpunkten: Die Behandlungsgruppe verzeichnete eine 24%ige Reduktion der Knieschmerzen und eine 26%ige Verbesserung der Kniefunktion gegen眉ber Placebo.
Bei altersbedingter prim盲rer Arthrose waren die Ergebnisse noch beeindruckender: Eine 72%ige Reduktion der Knieschmerzen und eine 95%ige Verbesserung der Kniefunktion im Vergleich zu Placebo, was in typischen prim盲ren Endpunkten einer Phase-III-Studie statistisch signifikante Effekte ergab. Die Behandlung wies ein g眉nstiges Sicherheitsprofil ohne schwere unerw眉nschte Ereignisse auf; berichtete Nebenwirkungen waren leicht bis m盲脽ig, vor眉bergehend und behandelbar.
- Significant 72% reduction in knee pain for age-related primary osteoarthritis patients vs placebo
- Substantial 95% improvement in knee function in age-related primary osteoarthritis patients
- Overall positive results across all efficacy and secondary endpoints
- Favorable safety profile with no severe adverse events reported
- Most patients experienced some side effects, though mild to moderate and treatable
- Only 3-month topline data available, longer-term results still pending
Insights
Enlivex's Allocetra shows promising Phase I/II results for knee osteoarthritis, with remarkable efficacy in age-related cases.
The topline results from Enlivex's Phase I/II trial for Allocetra in moderate-to-severe knee osteoarthritis demonstrate encouraging efficacy signals with a favorable safety profile. In the overall modified intention-to-treat population, Allocetra produced a
However, the standout results came from the age-related primary osteoarthritis subgroup, which showed dramatic improvements: a
From a safety perspective, the drug demonstrated a favorable profile with no severe adverse events reported. Side effects were generally mild to moderate, transient, and treatable 鈥� a critical consideration for chronic conditions like osteoarthritis where long-term tolerability is essential.
These results are particularly notable in the osteoarthritis space, where developing effective treatments has proven challenging. The remarkable efficacy in the age-related subgroup suggests Allocetra's macrophage reprogramming approach may be particularly effective for this specific patient population, potentially enabling a targeted therapeutic strategy. The next critical milestones will likely include longer-term data to confirm durability of effect and preparations for pivotal Phase III studies.
ENX-CL-05-001 Trial: 3-months topline data
-聽聽聽In the overall modified intention-to-treat (mITT) population, improvements across all efficacy and secondary endpoints, including
-聽聽聽Favorable safety profile 鈥� No severe adverse events; limited, typically mild to moderate, transient, and treatable side effects occurred in most patients treated with Allocetra鈩�
-聽聽聽Webinar today at 8:00 a.m. Eastern Time
Nes-Ziona, Israel, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the 鈥淐ompany鈥�), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive three-month topline data from the Phase IIa stage of ENX-CL-05-001, a multi-center, two-stage Phase I/II double-blind, randomized, placebo-controlled clinical trial evaluating Allocetra鈩� in patients with moderate-to-severe knee osteoarthritis.
Oren Hershkovitz, Ph.D, CEO of Enlivex, commented, 鈥淲e are excited to share the topline three-month data from ENX-CL-05-001. We believe these results provide clear indication that Allocetra鈩� has the potential to become a novel, safe and effective treatment for knee osteoarthritis, a growing market with significant unmet medical need.鈥�
The Company will host a webinar today at 8:00 am Eastern Time to provide in-depth analysis of the results. To join the webinar, please click
To join the webinar, please register at:
It is suggested participants join the webinar at least 15 minutes prior to the scheduled start time to avoid any delays in attendance.
About ENX-CL-05-001
ENX-CL-05-001 is a multi-center Phase I/II clinical trial consisting of two stages. The first stage was a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra鈩� injections to the target knee, in order to identify the dose and injection regimen for the subsequent Phase IIa stage. The Phase IIa stage is a double-blind, randomized, placebo-controlled multi-centered trial. In addition to evaluating safety, the study protocol was designed to efficiently find a strong signal in a responder population to guide future development, and includes an interim statistical evaluation, conducted by an independent third party and blinded to the Company, to assess the potential value of enrollment of up to 50 patients in addition to the original randomized sample size of 130, and its marginal impact on the p-value of the statistical estimation of the total group and specifically to identify a potential responder sub-group. The trial鈥檚 key efficacy endpoints evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months post treatment.
ABOUT KNEE OSTEOARTHRITIS
Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with
ABOUT ENLIVEX
Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra鈩�, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening and life debilitating conditions. For more information, visit聽.
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as 鈥渆xpects,鈥� 鈥減lans,鈥� 鈥減rojects,鈥� 鈥渨ill,鈥� 鈥渕ay,鈥� 鈥渁nticipates,鈥� 鈥渂elieves,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥渃ould,鈥� 鈥渋ntends,鈥� 鈥渆stimates,鈥� 鈥渟uggests,鈥� 鈥渢arget,鈥� 鈥渉as the potential to鈥� and other words of similar meaning, including statements regarding expected cash balances, expected clinical trial results, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM聽programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex鈥檚 business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM聽product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex鈥檚 filings with the Securities and Exchange Commission, including in the Company鈥檚 most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.
ENLIVEX CONTACT
Shachar Shlosberger, CFO
Enlivex Therapeutics, Ltd.
INVESTOR RELATIONS CONTACT
Dave Gentry, CEO
RedChip Companies Inc.
1-407-644-4256
FAQ
What were the key results of Enlivex's (ENLV) Phase I/II Allocetra trial for knee osteoarthritis?
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